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Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease

Plain-language guide to NCT07651319: phase 1, phase 2 randomized trial of Semaglutide, dementia, alzheimer's & cognitive decline, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07651319
Phase
phase 1, phase 2
Status
recruiting participants
Start
2026-09-01
Completion (planned or actual)
2029-06
Participants
30 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Alzheimer Dementia (AD)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Semaglutide for dementia, alzheimer's & cognitive decline.

Alzheimer's disease (AD) is the most common cause of dementia.

It had three arms (groups): Placebo (placebo comparator), one (active comparator) and IL-2 Plus Semaglutide combination therapy (active comparator).

Placebo Administration.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 50 years up to 86 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female age 50 to 86 years. MMSE between 16-26. English language speaking. Formal education of eight or more years. A family member or caretaker who is expected to be consistently available, administer study drugs of IL-2 and attend study visits throughout the study.

The full record lists 12 inclusion and 33 exclusion criteria; among the exclusions: any untreated bacterial, fungal or viral infection; hepatic impairment indicated by alanine aminotransferase level (alt) and aspartate aminotransferase (ast) greater than two times normal; hypersensitivity or allergy to il-2.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The dementia, alzheimer's & cognitive decline participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the dementia, alzheimer's & cognitive decline participants stayed in one arm throughout.

Neither the dementia, alzheimer's & cognitive decline participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-09-01 with completion listed for 2029-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety and the tolerability of IL-2 plus Semaglutide in AD patients (time frame: 6 months treatment phase).

It also tracked 1 secondary outcome, for example The impact of IL-2 plus Semaglutide administration on the blood Treg population.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Semaglutide in 30 people with dementia, alzheimer's & cognitive decline.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Dementia, Alzheimer's & cognitive decline research.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.